A Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer.
- Conditions
- Breast cancerMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002455-42-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
- Women or men >= 18 years of age
- Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
- Confirmed diagnosis of HR+/HER2– breast cancer
- Metastatic or Locally Advanced disease not amenable to curative therapy
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- Consent to provide fresh or archival tumor tissue specimen
- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1; bone-only” disease, even if considered measurable, is not eligible
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of > 6 months
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- Ability, in the investigator’s judgment, and willingness to comply with all study-related procedures, including completion of patient-reported endpoints
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
- Metaplastic breast cancer
- Any history of leptomeningeal disease or carcinomatous meningitis
- Any prior systemic therapy for metastatic breast cancer
- Prior treatment with fulvestrant or any selective estrogen-receptor degrader
- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Inability or unwillingness to swallow pills or receive intramuscular injections
- Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases are eligible
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
- Symptomatic active lung disease, or requiring supplemental oxygen
- History of inflammatory bowel disease or active bowel inflammation
- Anti-cancer therapy within 2 weeks before study entry
- Investigational drug(s) within 4 weeks before randomization
- Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
- History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- History of or active clinically significant cardiovascular dysfunction
- Chronic corticosteroid therapy or immunosuppressants
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
- Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method